--- title: "Licence variation: spironolactone for acne in women market engagement" ocid: "ocds-b5fd17-23250de8-71a6-411f-a570-d4303c4eeeae" canonical_url: "https://d3tenders.com/contract/?ocid=ocds-b5fd17-23250de8-71a6-411f-a570-d4303c4eeeae" markdown_url: "https://d3tenders.com/contract/ocds-b5fd17-23250de8-71a6-411f-a570-d4303c4eeeae.md" json_url: "https://d3tenders.com/contract/ocds-b5fd17-23250de8-71a6-411f-a570-d4303c4eeeae.json" source: "Contracts Finder" current_stage: "Planning" buyer: "NHS ENGLAND" published: "2025-02-26" --- # Licence variation: spironolactone for acne in women market engagement Buyer: NHS ENGLAND Current stage: Planning OCID: ocds-b5fd17-23250de8-71a6-411f-a570-d4303c4eeeae [View canonical contract page](https://d3tenders.com/contract/?ocid=ocds-b5fd17-23250de8-71a6-411f-a570-d4303c4eeeae) [Download OCDS JSON](https://d3tenders.com/contract/ocds-b5fd17-23250de8-71a6-411f-a570-d4303c4eeeae.json) ## Summary NHS England has initiated a planning process for the "Licence variation: spironolactone for acne in women market engagement," under the health services industry category. This procurement process, conducted by NHS England located at 7-8 Wellington Street, Leeds, is in the planning stage. The key date to note is the deadline for responses, which is 14 March 2025 at 12 noon. The market engagement started on 26 February 2025, and potential suppliers can register their interest and obtain a Request for Information (RFI) documentation through the Atamis portal. This initiative includes two contracts, one for preparing a major MHRA Marketing Authorisation variation for spironolactone and another for submitting the application to the MHRA. This tender presents an excellent opportunity for businesses in the health services and project management consultancy sectors to engage with NHS England in a substantial project aimed at enhancing treatment options for acne in women. Companies specializing in regulatory submissions, risk management, and clinical documentation would find this tender particularly suitable. Small and medium-sized enterprises (SMEs) are encouraged to participate, given the suitability criteria outlined in the procurement notice. This initiative provides a platform for companies to collaborate closely with NHS England, potentially leading to a long-term partnership and the chance to contribute to significant advancements in women's health. ## Notice NHS England has published this Preliminary Market Engagement Notice. It is anticipated that there will be two separate contracts to deliver this, as outlined below. * Contract A: Prepare an application for a major (type II) MHRA Marketing Authorisation variation for spironolactone. * Contract B: Submit the pre-prepared application to the MHRA. Only current Marketing Authorisation Holders of spironolactone are eligible to bid for contract B. The licence variation is to add a new indication to the current licence (marketing authorisation) for spironolactone, for treating acne in women. For contract A, the Successful Supplier would need to prepare a dossier for the MHRA including: * A Risk Management Plan * Clinical Overview * Revised Summary of Product Characteristics and Patient Information Leaflet * Responses to the MHRA's Request(s) for Further Information. For contract B, the Successful Supplier would need to: * Review the draft regulatory modules and supporting documents prepared by contractor A and either confirm they are complete, or request revisions. * Use the final regulatory modules and supporting documents to apply for a major type II licence variation from the MHRA. * If granted, update the Summary of Product Characteristics and Patient Information Leaflet with the new indication and related data. NHS England would like to gather soft intelligence from the market and is publishing a Request for Information for the two contracts. NHS England would also be pleased to offer 1:1 meetings with potential Suppliers to discuss this innovative partnership approach. The Request for Information and further documentation will be available from 26 February 2025 and the deadline for responses will be 14 March 2025 at 12 noon and 1:1 meetings will be 12 noon on 11 March 2025. To register an interest in responding to this market engagement exercise and obtain a copy of the Request for Information documentation please go to: http://health.atamis.co.uk. All communications and Request for Information submissions will be conducted via Atamis. The portal can be accessed at any time of the day and it is free to register. This notice signals the intention to conduct an information gathering exercise only. This notice does not constitute a call for competition in its own right. Publication of this notice and/ or any responses to it does not commit NHS England and/or respondents to undertaking or participating in any future procurement process, nor does it provide any process exemptions or preferential treatment to any parties expressing an interest. NHS England will not be liable for costs incurrent by any interested party in participating in the information exercise howsoever arising. ## Key Details | Field | Value | | --- | --- | | Publication source | Contracts Finder | | Latest notice | https://www.contractsfinder.service.gov.uk/Notice/d1d7397f-10cc-485d-accd-931a59f3bdb2 | | Notice type | Market Engagement Notice | | Procurement type | Standard | | Procurement category | Services | | Procurement method | Not Specified | | Procurement method details | Not specified | | Tender suitability | SME | | Awardee scale | Not specified | | All stages | Planning | ## Dates | Field | Value | | --- | --- | | Publication date | 26 Feb 2025 | | Submission deadline | Not specified | | Future notice date | 14 Mar 2025 | | Award date | Not specified | | Contract period | Not specified | | Recurrence | Not specified | ## Values | Field | Value | | --- | --- | | Tender value | Not specified | | Lots value | Not specified | | Awards value | Not specified | | Contracts value | Not specified | ## Status | Field | Value | | --- | --- | | Tender status | Planning | | Lots status | Not specified | | Awards status | Not specified | | Contracts status | Not specified | ## Buyer | Field | Value | | --- | --- | | Main buyer | NHS ENGLAND | | Locality | LEEDS | | Post town | Leeds | | Postcode | LS1 4AP | | Country | England | | ITL 1 | TLE Yorkshire and The Humber | | ITL 2 | TLE4 West Yorkshire | | ITL 3 | TLE42 Leeds | | Local authority | Leeds | | Electoral ward | Hunslet & Riverside | | Westminster constituency | Leeds South | | Delivery location | TLC North East (England), TLD North West (England), TLF East Midlands (England), TLG West Midlands (England), TLH East (England), TLJ South East (England), TLK South West (England) | ## CPV Codes ### Divisions - 72 - IT services: consulting, software development, Internet and support - 85 - Health and social work services ### Codes - 72224000 - Project management consultancy services - 85100000 - Health services ## Release History - 26 Feb 2025 at 16:51 - Planning - Market Engagement Notice - https://www.contractsfinder.service.gov.uk/Notice/d1d7397f-10cc-485d-accd-931a59f3bdb2 ## Documents - https://www.contractsfinder.service.gov.uk/Notice/d1d7397f-10cc-485d-accd-931a59f3bdb2 26th February 2025 - Early engagement notice on Contracts Finder ## Notice URLs - http://health.atamis.co.uk ## Provenance This Markdown file is an alternate public rendering of the D3 Tenders contract record. The canonical page is https://d3tenders.com/contract/?ocid=ocds-b5fd17-23250de8-71a6-411f-a570-d4303c4eeeae. The underlying structured data is available as OCDS JSON at https://d3tenders.com/contract/ocds-b5fd17-23250de8-71a6-411f-a570-d4303c4eeeae.json.